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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078527

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NDA 078527 describes FLUMAZENIL, which is a drug marketed by Baxter Hlthcare Corp, Fresenius Kabi Usa, Hikma Farmaceutica, Mylan Labs Ltd, Sagent Pharms, Sandoz Inc, Teva Pharms Usa, and West-ward Pharms Int, and is included in nine NDAs. It is available from fifteen suppliers. Additional details are available on the FLUMAZENIL profile page.

The generic ingredient in FLUMAZENIL is flumazenil. There are four drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the flumazenil profile page.
Summary for 078527
Tradename:FLUMAZENIL
Applicant:Hikma Farmaceutica
Ingredient:flumazenil
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078527
Medical Subject Heading (MeSH) Categories for 078527
Suppliers and Packaging for NDA: 078527
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUMAZENIL flumazenil INJECTABLE;INJECTION 078527 ANDA West-Ward Pharmaceutical Corp 0143-9683 N 0143-9683-10
FLUMAZENIL flumazenil INJECTABLE;INJECTION 078527 ANDA West-Ward Pharmaceutical Corp 0143-9684 N 0143-9684-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5MG/5ML (0.1MG/ML)
Approval Date:Mar 23, 2009TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/10ML (0.1MG/ML)
Approval Date:Mar 23, 2009TE:APRLD:No

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